Fday said:
I see, "proven" safe and effective like thalidomide and Viox, and the IUD, and . . . the list goes on and on.
And, even if a drug does work and is on the market doesn't mean it gets used properly. Just look at the influence of direct to patient marketing by the drug manufacturers. More people probably taking more expensive drugs they don't need now because some doctors don't know how to say no.
Frank
The drugs work as expected. There is just a human nature problem. For some reason sane humans think that a drug or device should not harm anyone. When it starts to link to 100 or so deaths, they get pulled.
My mother is still on a Cox2 inhibitor (if that is the correct way to describe it) that will not be prescribe by a doctor to a new paitent. Her doctor has tried to take her off of it a couple of times. She may have found a new drug to substitute for it finally. But until now my mother, myself, and her doc. have all discussed the side effects. My mother decided she would rather take the risk then live with the pain she was in without the drug. So yes, you would probably not be on the drug, but that does not mean the drug is not effective.
Likewise, she when through another drug treatment that has been determined safe. It turns out there were side effects with her other medications. The drug that caused the side effect did its job, it is just the tests are not fail safe. The drug manufacture will hopefully test for these side effects.
The brest implant issue has since been determind to have not caused the problems once thought. Yes they leaked, but now it appears Dow was put out of business by a bunch of lawyers that were wrong.
As for your product, I think it would be safe to say after you had the research completed. Not everyone would see the same results. Some would see more, some would see less. That is to be expected.
However, people would not really care because mostlikly people would not die.